At a glance
ClinicalIndex Comparison RecordPhase 1Recruiting· 10 target
Drug / intervention
CD19 CAR-T-cells +1 morebiological
Likely dose
Tocilizumab 8 mg/kgfrom record
Key inclusion· 3
- ✓CD19-positive relapsed or refractory B-cell lymphoblastic leukemia or lymphoma
- ✓Written informed consent required
- ✓Sufficient peripheral blood T-cell count above 150 cells/µL
Key exclusion· 9
- ✕Primary immunodeficiencies or genetic syndromes
- ✕Neurologic diseases
- ✕Autoimmune diseases or polyallergies
- ✕Donor lymphocyte transfusion within 6 weeks before CAR-T infusion
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT05333302Phase 1RecruitingUpdate OverdueUpdated 22mo ago · Completion was 18mo agoEnrollment Stalled
Long Recruiting
Update Overdue
Pilot Study of CD19 CAR-T Cells Therapy for Relapsed or Refractory Acute Lymphoblastic Leukemia/Lymphoma in Children/Young Adults
Belarusian Research Center for Pediatric Oncology, Hematology and Immunology·interventional·Posted Apr 18, 2022·Updated Aug 28, 2024
In Brief
A Phase 1 clinical trial evaluating CD19 CAR-T-cells and Tocilizumab for B-cell Acute Lymphoblastic Leukemia and Lymphoblastic B-Cell Lymphoma. Currently recruiting, targeting 10 participants across 1 site.
Signals
Enrollment appears stalled
Detailed Summary
The purpose of this study is to estimate the safety and the efficacy of CAR- T cells immunotherapy for children/young adults with relapsed or refractory acute lymphoblastic leukemia/lymphoma.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelarus
Collaborators--
Timeline
Phase 1RecruitingOverdue
202120222023202420252026
Enrollment StartOct 2020
First PostedApr 2022
Primary CompletionDec 2024
Study CompletionJun 2025
TodayJul 2026
First PostedApr 18, 2022
Enrollment StartOct 26, 2020
Primary CompletionDec 1, 2024
Study CompletionJun 1, 2025
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 4.2 years ago
Interventions
CD19 CAR-T-cellsbiological
One dose of CD19 CAR-T cells (1\*10e6 CAR+ T-cells/kg) by intravenous infusion.
Tocilizumabdrug
Before 1h of CAR-T cells infusion a patient receive tocilizumab (8 mg/kg).